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| Mechanical
characterization of coronary endoprostheses |
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(cf
A9, A16, A17, C14,
C15, C26, C27, C42, C50, C51, C52, C53).
During the 90s, endovascular methods have started to stand as
a major alternative to classical surgery. Stents allow to restore
the initial caliber or arteries damaged by stenosing lesions.
As practicians revealed problems possibly due to the mechanical
comportment of the prosthesis itself, the production of several
test benches seemed necessary to evaluate the mechanical properties
of these materials while respecting the international standards
being currently defined. The good long-term results of the "stenting"
depend among others reasons on the hemocompatibility, on the
resistance to crushing, on a limited "recoil" (elastic feedback),
as well as on the difficulty of installation (path to the implementation
area and deploy).
Angioplasty is recommended in the treatment of vascular atheromateous
stenosing lesions. This technology consists in inflating a small
balloon inside of the artery in order do dilate the stenosed
segment. Plates are then destroyed by fragmentation and crushing.
However, after a such intervention, various phenomena can occur
and involve a restenosis. On the one hand, the endothelium which
covers the vascular lining is damaged, what favors the multiplication
of cells from the subendothlial tissue, as well as the adhesion
of the platelets, and thus the formation of thrombuses. On the
other hand, two major lacks of parietal remolding are to be
taken into account. The first one is the precocious elastic
recoil which takes place in the 15 min following the angioplasty.
It is only related to the mechanical properties of the vascular
lining. The second one is a bad cicatrizing of the lining which
is visible by a contraction of the artery which leads to a restriction
of the vascular aperture. That is the reason why this technology
is often accompanied by the implementation of an endoprosthesis
(or stent) at the level of the lesion. After (or during) the
angioplasty, the endoprosthesis is fitted in the dilated segment.
Its structure allows to keep the vascular aperture open, and
to avoid the inauspicious effects of the parietal remoulding,
to prevent restenosis. Further on, by maximizing the size of
the vessel, the impact of a fibromuscular growth inside the
artery is minimized. The endoprosthesis only permits anyway
to reduce the probability of restenosis after angioplasty, but
not to totally avoid it. The ratio of restenosis after 6 months
goes from about 35% for a angioplasty alone to 15-20% for an
angioplasty accompanied by the implant of an endoprosthesis.
Several parameters, such as the size or the shape of the stitches
as well as the metal used, characterize the mechanical comportment
of the endoprosthesis., and can have an influence on the restenosis.
By now, many research works aim at linking the characteristics
of endoprostheses to the 6-months rate of restenosis. When an
endoprosthesis is installed in a sick artery with a view to
mechanically sustaining it, it is important that the section
of the blood flow (or artery aperture) within the endoprosthesis
is of a dimension close to the initial section of flow of the
sane artery so that the risks of restenosis are reduced. The
goal of these studies lead in collaboration with Dr Paul Barragan
(Beauregard Clinic, Marseille) is to predict the mechanical
comportment of the endoprosthesis after its implementation.
The test benches which were developed allow to present reliable
evaluating systems of the mechanical characteristics of endoprostheses,
as recommanded by the European norms. (EN 12006-3, January 1999),
which shall be used by industrials whether in their demand of
being CE labeled, or in their process of quality policy, or
for research & development purpose.
. Radial resistance to compression
We evaluated the resistance to crushing of most of the coronary
prostheses comercially available (27 models). The aim was to
measure the distortion that the small caliber prostheses undergo,
when they are submitted to external constraints such as those
exerted by the arterial lining, and to evaluate their resistance
to extreme forces. The results, which appeared in a publication
at Cathetherisation and Cardiovascular Interventions (A16),
shown that all the studied endoprostheses, while having each
their own mechanical characteristics, were resistive enough
to have a sane comportement after implementation. That is the
reason why we focused our researches on another mechanical parameter
of the stents, which is the intrinsic elastic recoil, which
is of major importance, regarding the final diameter of the
stented artery. In fact, an endoprosthesis dilated to a determined
diameter naturally returns to an infirior diameter after deflation
due to internal constraints. This recoil is more important when
external constraints (even small) are applied by the lining
to the endoprosthesis.
. Elastic recoil
This study aimed at determining in vitro the elastic recoil
of 22 usual coronary endoprostheses dilated of 3.0 mm, using
a device of optical measure of a great precision (SMARTSCOPE
MVP 200; precision 1mm). A minimal recoil allows to adjust the
final diameter of the stent to the nominal diameter of the artery;
the more important the recoil, the more necessary it will be
to over-dilate the endoprosthesis, and so the artery, with as
a consequence an inauspicious impacting of the stent in the
artery.

Estimation of the in vitro elastic recoil when constrained
on 22 coronary endoprostheses.
The results clearly show that, depending on the design of the
endoprosthesis (monofilament, laser cut tubular, hybrid), the
important differences observed on the measured elastic recoil
(between 2 and 18%), which can provoke, after a theoretical
launch at a 3.0 mm diameter, a decrease of 0.5 mm on the final
diameter. These results, which are currently being published
(A17) have also
pointed out a correlation between the elastic recoil and the
restenosis rate after 6 months evaluated during several randomized
clinical studies with various materials.
. Evaluation of the trudging stress
These tests were conducted with four commercial stents : Crossflex,
CR153, PS153, PS154. For each model, six stents were successively
tested. Over the four models of stents, only the Crossflex was
delivered crimped on a dilatation catheter (CORDIS balloon).
For the other models, we have conducted the tests with three
stents crimped on a CORDIS balloon, and three stents crimped
on a Bard SAMBA balloon. Five essential points emerge from that
study :
1/ The results for the Crossflex stents were the same for tests
separated by two weeks, which confirms the good repeativity
of our tests.
2/ We came to a classification on grounds of their easiness
to trudge into the tortuosities, which is, by order of growing
difficulty : Crossflex, PS 153, CR 153, and PS 154 (this classification
is confirmed by the practician).
3/ For a given stent, the more tortuous the artery is, the higher
is the force to be applied to the stent for the passing through.
4/ The balloon on which the stent is crimped has a non-neglectable
role : for whatever stent, the required force to have it pass
through a tortuosity is always inferior when the balloon CORDIS
is used in comparison with the balloon Bard SAMBA.
5/ The typical gap ever noticed in the results of the test lead
with the PS154 stent is probably linked to the rigidity of this
stent. Its rigidity causes the manner in which the stent arrives
at the beginning of the tortuosity to have a significant influence
on the intensity of the force to provide.

Results of the tests of trackability
in module 3
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